PE20071139A1 - SUSTAINED RELEASE FORMULATION INCLUDING OCTREOTIDE AND TWO OR MORE POLYLACTIDE-CO-GLYCOLIDE POLYMERS - Google Patents

SUSTAINED RELEASE FORMULATION INCLUDING OCTREOTIDE AND TWO OR MORE POLYLACTIDE-CO-GLYCOLIDE POLYMERS

Info

Publication number
PE20071139A1
PE20071139A1 PE2006001665A PE2006001665A PE20071139A1 PE 20071139 A1 PE20071139 A1 PE 20071139A1 PE 2006001665 A PE2006001665 A PE 2006001665A PE 2006001665 A PE2006001665 A PE 2006001665A PE 20071139 A1 PE20071139 A1 PE 20071139A1
Authority
PE
Peru
Prior art keywords
polymers
sustained release
polylactide
release formulation
formulation including
Prior art date
Application number
PE2006001665A
Other languages
Spanish (es)
Inventor
Holger Petersen
Markus Ahlheim
Original Assignee
Novartis Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=37772904&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PE20071139(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from GB0526247A external-priority patent/GB0526247D0/en
Application filed by Novartis Ag filed Critical Novartis Ag
Publication of PE20071139A1 publication Critical patent/PE20071139A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08—Peptides having 5 to 11 amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/31—Somatostatins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12—Antidiarrhoeals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/02—Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • A61P5/08—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH for decreasing, blocking or antagonising the activity of the anterior pituitary hormones

Abstract

SE REFIERE A UNA COMPOSICION FARMACEUTICA DE LIBERACION SOSTENIDA QUE COMPRENDE a) COMO INGREDIENTE ACTIVO OCTEOTRIDA O UNA SAL FARMACEUTICAMENTE ACEPTABLE SIENDO PREFERIDA LA SAL DE PAMOATO DE OCTEOTRIDA; Y b) DOS O MAS DIFERENTES POLIMEROS DE POLIACTIDO-CO-GLICOLIDO (PLGAs), PRESENTES COMO MEZCLA DE POLIMEROS, QUE TIENEN UNA RELACION DE MONOMERO DE LACTIDO:GLICOLIDO DE 100:0 A 40:6O, Y LA VISCOCIDAD INHERENTE DE LOS POLIMEROS ESTA POR ABAJO DE 0.9 DL/G EN CLOROFORMO. ESTA COMPOSICION PUEDE PRESENTARSE BAJO LA FORMA DE MICROPARTICULAS CON UN DIAMETRO ENTE 10 um A 90 um LAS CUALES SON REVESTIDAS CON UN AGENTE ANTI-AGLOMERACION, UN SEMI-SOLIDO U UN IMPLANTE, OBTENIENDOSE ASI UNA LIBERACION DEL INGREDIENTE ACTIVO DE 3 A MAS MESESREFERS TO A SUSTAINED RELEASE PHARMACEUTICAL COMPOSITION THAT INCLUDES a) AS ACTIVE INGREDIENT OCTEOTRIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT, THE SALT OF OCTEOTRIDE PAMOATE BEING PREFERRED; AND b) TWO OR MORE DIFFERENT POLYACTIDE-CO-GLYCOLIDE POLYMERS (PLGAs), PRESENT AS A MIX OF POLYMERS, WHICH HAVE A LACTIDE MONOMER: GLYCOLIDE RATIO OF 100: 0 TO 40: 6O, AND THE INHERENT VISCOCITY OF THE POLYMERS IT IS BELOW 0.9 DL / G IN CHLOROFORM. THIS COMPOSITION CAN BE PRESENTED IN THE FORM OF MICROPARTICLES WITH A DIAMETER BETWEEN 10 um TO 90 um WHICH ARE COATED WITH AN ANTI-AGGLOMERATION AGENT, A SEMI-SOLID OR AN IMPLANT, OBTAINING A RELEASE OF THE MASS ACTIVE INGREDIENT OF 3 TO MASS ACTIVE INGREDIENTS

PE2006001665A 2005-12-22 2006-12-20 SUSTAINED RELEASE FORMULATION INCLUDING OCTREOTIDE AND TWO OR MORE POLYLACTIDE-CO-GLYCOLIDE POLYMERS PE20071139A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0526247A GB0526247D0 (en) 2005-12-22 2005-12-22 Organic compounds
EP06119086 2006-08-17

Publications (1)

Publication Number Publication Date
PE20071139A1 true PE20071139A1 (en) 2007-11-16

Family

ID=37772904

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2006001665A PE20071139A1 (en) 2005-12-22 2006-12-20 SUSTAINED RELEASE FORMULATION INCLUDING OCTREOTIDE AND TWO OR MORE POLYLACTIDE-CO-GLYCOLIDE POLYMERS

Country Status (22)

Country Link
US (6) US20090004283A1 (en)
EP (3) EP1968549B1 (en)
JP (4) JP2009520727A (en)
KR (5) KR20140133968A (en)
CN (1) CN103251929A (en)
AR (1) AR058591A1 (en)
AU (1) AU2006328950B2 (en)
BR (2) BRPI0620063B8 (en)
CA (1) CA2631811C (en)
CL (1) CL2018003398A1 (en)
EC (1) ECSP088560A (en)
ES (2) ES2755032T3 (en)
IL (1) IL191842A0 (en)
IN (1) IN2015DN03936A (en)
MA (1) MA30064B1 (en)
NO (1) NO20082988L (en)
PE (1) PE20071139A1 (en)
PL (2) PL1968549T3 (en)
PT (2) PT1968549E (en)
RU (1) RU2464972C2 (en)
TW (2) TWI469788B (en)
WO (1) WO2007071395A1 (en)

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Also Published As

Publication number Publication date
US20150037420A1 (en) 2015-02-05
TWI469788B (en) 2015-01-21
KR101458728B1 (en) 2014-11-05
JP2015044823A (en) 2015-03-12
BR122019027412B1 (en) 2020-12-01
AU2006328950B2 (en) 2010-07-29
US20200206306A1 (en) 2020-07-02
KR20140133968A (en) 2014-11-20
EP3603623A1 (en) 2020-02-05
EP1968549B1 (en) 2014-05-14
TW201424747A (en) 2014-07-01
JP6239851B2 (en) 2017-11-29
PT1968549E (en) 2014-08-29
TWI468172B (en) 2015-01-11
MA30064B1 (en) 2008-12-01
KR20130024987A (en) 2013-03-08
JP6178772B2 (en) 2017-08-09
BR122019027412B8 (en) 2021-07-27
EP2359809A1 (en) 2011-08-24
PT2359809T (en) 2019-11-04
CN103251929A (en) 2013-08-21
CA2631811A1 (en) 2007-06-28
BRPI0620063B8 (en) 2021-05-25
IN2015DN03936A (en) 2015-10-02
JP2016216467A (en) 2016-12-22
KR101245919B1 (en) 2013-03-20
US20160120935A1 (en) 2016-05-05
PL1968549T3 (en) 2014-10-31
BRPI0620063B1 (en) 2020-09-08
BRPI0620063A2 (en) 2011-11-01
JP2013177406A (en) 2013-09-09
EP2359809B1 (en) 2019-08-14
US20090004283A1 (en) 2009-01-01
WO2007071395A1 (en) 2007-06-28
RU2464972C2 (en) 2012-10-27
CA2631811C (en) 2017-06-20
AR058591A1 (en) 2008-02-13
US20220296675A1 (en) 2022-09-22
BRPI0620063A8 (en) 2018-05-02
EP1968549A1 (en) 2008-09-17
KR20130024988A (en) 2013-03-08
NO20082988L (en) 2008-08-29
PL2359809T3 (en) 2020-01-31
TW200803921A (en) 2008-01-16
ES2492641T3 (en) 2014-09-10
JP2009520727A (en) 2009-05-28
KR20080078000A (en) 2008-08-26
US20180140662A1 (en) 2018-05-24
RU2008129626A (en) 2010-01-27
ECSP088560A (en) 2008-07-30
CL2018003398A1 (en) 2019-04-26
ES2755032T3 (en) 2020-04-21
AU2006328950A1 (en) 2007-06-28
KR20130024986A (en) 2013-03-08
IL191842A0 (en) 2008-12-29

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